Consumer medicine information

What is in this leaflet

Read this leaflet carefully before you start to use Maxidex Eye Drops.

This leaflet answers some common questions about Maxidex Eye Drops. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

The information in this leaflet was last updated on the date listed on the final page. More recent information on the medicine may be available.

You should ensure that you speak to your pharmacist or doctor to obtain the most up to date information on the medicine.

You can also download the most up to date leaflet from www.novartis.com.au The updates may contain important information about the medicine and its use of which you should be aware.

All medicines have risks and benefits. Your doctor has weighed the risks of you using Maxidex against the benefits they expect it will have for you.

If you have any concerns about using this medicine, ask your doctor or pharmacist.

Keep this leaflet with your medicine. You may need to read it again.

What Maxidex is used for

Maxidex contains dexamethasone which is a type of cortisone. It belongs to the group of medicines called corticosteroids

Maxidex is used to treat:

• the redness, swelling and other symptoms due to inflammation or allergy of the eye
• injury of the cornea caused by chemical, heat burns or foreign bodies.

Before prescribing Maxidex Eye Drops for you, your doctor will have examined your eye(s) and decided that Maxidex Eye Drops is the right medicine for you.

Your doctor may have prescribed Maxidex for another purpose.

Ask your doctor if you have any questions about why Maxidex has been prescribed for you.

Maxidex is not addictive.

This medicine is available only with a doctor's prescription.

Use in children

Maxidex is not for use in children. The safety and effectiveness of Maxidex in children has not been established.

Before you use Maxidex

When you must not use it

Do not use Maxidex if you have an allergy to:

• dexamethasone or any of the ingredients listed at the end of this leaflet under "Product description"
• any other corticosteroid medicine.

Some of the symptoms of an allergic reaction may include:

• shortness of breath, wheezing or difficulty breathing
• swelling of the face, lips, tongue or other parts of the body
• rash, itching or hives on the skin.

Do not use Maxidex Eye Drops if:

• the safety seal around the closure and neck area is broken
• the bottle/packaging shows signs of tampering
• the expiry date on the bottle/carton has passed.
  If you use this medicine after the expiry date has passed, it may not work.

Do not put the eye drops into your eye(s) while you are wearing soft contact lenses. The preservative in Maxidex Eye Drops, benzalkonium chloride, may be deposited in soft contact lenses. You can put your soft contact lenses back into your eyes 15 minutes after you have used Maxidex Eye Drops.

Do not use Maxidex Eye drops if you have an eye infection including:

• a viral infection
• a bacterial infection
• a fungal infection
• a parasitic infection
• tuberculosis of the eye.

If you are not sure whether you should start using Maxidex Eye Drops, talk to your doctor.

Before you start to use it

Tell your doctor if:

• you have allergies to any other medicines or any substances such as foods, preservatives or dyes
• you are pregnant or intend to become pregnant
  Maxidex is not recommended in pregnant women. Your doctor will discuss the risks and benefits of using Maxidex Eye Drops when pregnant.
• you are breastfeeding or intend to breastfeed.
  Your doctor will discuss the risks and benefits of using Maxidex Eye Drops when breastfeeding.

Tell your doctor if you have the following medical conditions:

• Sjogren's keratoconjunctivis
• History of glaucoma, high myopia or family history of these conditions
• Prone to increase in the pressure in the eye e.g. in diabetes
• An infection due to a bacteria, virus, fungus or a parasite.
  This medication may mask these infections or suppress the immune system leading to further infections of the eye.
• Diseases that cause thinning of the cornea or sclera.

If you have not told your doctor about any of the above, tell him/her before you start to use Maxidex Eye Drops.

Using other medicines

Tell your doctor or pharmacist if you are using other eye drops or taking any medicine. This includes any that you buy without a prescription from a pharmacy, supermarket or health food shop.

Tell your doctor if you are using the following medicines:

• Other corticosteroids or steroid medicines
• Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
• Medicines used to treat viral infections e.g. ritonavir or cobicistat
• Anticholinergic drugs such as atropine.

These medicines may be affected by Maxidex or may affect how well it works. You may need different amounts of your medicines, or you may need to use different medicines. Your doctor and pharmacist have more information on medicines to be careful with or avoid while using this medication.

How to use Maxidex

How much to use

Follow all directions given to you by your doctor and pharmacist carefully. They may differ from the information contained in this leaflet.

The dosing instructions will be printed on the label that your pharmacist puts on the bottle or carton.

If you do not understand the instructions on the label, ask your doctor or pharmacist for help.

How much to use

The dose of Maxidex will depend on the severity of your condition.

If your condition is severe, the usual dose of Maxidex is one to two drops in the affected eye(s) every hour.

The number of times that you will need to use Maxidex will decrease as the inflammation settles before finally stopping the eye drops.

If your condition is mild, the usual dose of Maxidex is one to two drops in the affected eye(s) up to four to six times a day.

How to use it

It is important to use Maxidex exactly as your doctor or pharmacist has told you. If you use it less often than you should, it may not work as well and your eye problem may not improve. Using it more often than you should may not improve your eye problem any faster and may cause side effects.

Do not touch the tip of the dropper tip with your fingers, to the eye or any other surface. This will help prevent the eye drops becoming dirty or contaminated.

If you wear soft contact lenses, remove your contact lenses before using this medicine. Wait for 15 minutes after using it before reinserting your contact lenses into your eyes.

Follow these steps to use Maxidex:

1. Wash your hands thoroughly
2. Shake the bottle well before using
3. Remove the cap from the bottle.
4. Immediately before using a bottle for the first time, break the safety seal around the neck area and throw the loose plastic ring away
5. Hold the bottle upside down in one hand between your thumb and middle finger (see Diagram 1).

6. Tilt your head back and look up.
7. Using your other hand, gently pull down the lower eyelid to form a pouch or pocket.
8. Put the tip of the dropper close to, but not touching your eye. Release the required number of drops into the pouch/pocket formed between the eye and eyelid by gently squeezing the side of the bottle (see Diagrams 2 and 3).

9. Close the eye gently and press on the inside corner of the eye with the pad of your index finger for 2 minutes.
10. If necessary repeat the above steps 5-9 for your other eye.
11. Replace the cap on the bottle, closing it tightly.
12. Wash your hands again with soap and water to remove any residue.

After using Maxidex wait at least 5 minutes before putting any other eye drops in your eye(s). Ointments should be administered last.

How long to use it

Your doctor or pharmacist will tell you how long to use Maxidex.

Do not use Maxidex for longer than your doctor tells you. If you use Maxidex for longer than your doctor or pharmacist tells you, the chance of side effects may increase.

If you are not sure how long to use Maxidex, talk to your doctor or pharmacist.

If you forget to use it

If you forget to use Maxidex, you should put the drops that you missed in the eye(s) as soon as you remember, and then go back to using them as recommended by your doctor. If it is almost time for your next dose, skip the dose you missed and continue using them as recommended.

Do not use a double dose to make up for the dose that you missed.

If you have trouble remembering to use your medicine, ask your pharmacist for some hints.

If you use too much (overdose)

If you accidentally put too many drops in your eye(s) immediately rinse your eye(s) with warm water.

Immediately telephone your doctor or the nearest Poisons Information Centre on 13 11 26 or go to Accident and Emergency at the nearest hospital, if you think that you or someone else has swallowed Maxidex. Do this even if there are no signs of discomfort or poisoning.

While you are using Maxidex

Things you must do

If you are about to be started on any medicine, remind your doctor and pharmacist that you are using Maxidex.

Tell any other doctors, dentists and pharmacists who are treating you that you are using MAXIDEX.

If you feel that MAXIDEX is not helping your condition, tell your doctor (or pharmacist).

Keep all your doctor's appointments so that your progress can be checked.

Tell your doctor if, for any reason, you have not used Maxidex exactly as prescribed. Otherwise, your doctor may think that it was not effective and change your treatment unnecessarily.

Tell your doctor if you experience swelling and weight gain around the trunk and in the face, it may be symptoms of a hormonal imbalance known as Cushing's syndrome. Talk to your doctor before stopping the treatment by yourself. Stopping long term or intensive treatment with Maxidex may cause your adrenal glands to not work properly. These risks are especially important in children and patients treated with medicine containing ritonavir or cobicistat.

Tell your doctor immediately if you become pregnant while using Maxidex.

Things you must not do

Do not stop using Maxidex without first asking your doctor.

Do not use Maxidex to treat other complaints unless your doctor or pharmacist tells you to.

Do not give Maxidex to anyone else, even if they have the same symptoms as yours.

Do not let children handle Maxidex.

Things to be careful of

You should not drive or operate any machinery if Maxidex affects your vision (blurred vision).

Ask your doctor or pharmacist if you are concerned about the length of time you have been using Maxidex.

Side effects

Tell your doctor as soon as possible if you do not feel well while using Maxidex.

This medicine helps most people with treating eye inflammation but it may have unwanted effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Tell your doctor or pharmacist if you notice any of the following and the worry you:

• Glaucoma.
  Some of the symptoms of glaucoma include pain, discomfort, irritability or redness of the eye, change in vision, seeing "halos" or sensitivity to light.
  Your doctor will need to check your eyes to determine if you have glaucoma.
• eye discomfort, grittiness, itchiness, irritation, pain
• dry or watery eyes
• red eye
• blurred vision
• inflammation of the eye
• secondary eye infection
• staining front part of the eye
• drooping eyelid
• crustiness of eyelid
• dilated pupil
• sensitivity to sunlight
• corneal erosion (front part of the eye shedding abnormally)

Occasionally some people notice unwanted effects in the rest of their body as a result of using Maxidex Eye Drops. These effects may include:

• allergy
• bad taste in the mouth
• dizziness
• headache
• hormonal imbalance (higher or lower than normal levels).
• Hormone problems: growth of extra body hair (particularly in women), muscle weakness and wasting, purple stretch marks on body skin, increased blood pressure, irregular or missing periods, changes in the levels of protein and calcium in your body, stunted growth in children and teenagers and swelling and weight gain of the body and face (called 'Cushing's syndrome')

Tell your doctor immediately and stop using Maxidex at the first sign of a skin rash or any other sign of allergy (e.g. hives).

Other side effects not listed above may also occur in some patients. Tell your doctor if you notice anything else that is making you feel unwell while using Maxidex.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

After using Maxidex

Storage

Keep Maxidex in a cool dry place where the temperature stays below 25°C.

Do not freeze Maxidex.

Do not store Maxidex or any other medicine in the bathroom or near a sink. Do not leave it in the car or on window sills. Heat and dampness can destroy some medicines.

Keep Maxidex in a safe place away from the sight or reach of children. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Put the top back on the bottle right away after use to avoid contamination.

Disposal

Write the date on the bottle when you open the eye drops and throw away any remaining solution after 4 weeks. Eye drops contain a preservative which helps prevent germs growing in the solution for the first four weeks after opening the bottle. After this time there is a greater risk that the drops may become contaminated and cause an eye infection. A new bottle should then be used.

If your doctor tells you to stop using Maxidex or it has passed its expiry date, ask your pharmacist what to do with any that is left over.

Product description

What it looks like

Maxidex is a white to pale yellow, opaque suspension that comes in a 5mL plastic dropper bottle.

Ingredients

The active ingredient in Maxidex Eye Drops is dexamethasone 1 mg in 1 mL.

Maxidex Eye Drops also contain:

• Benzalkonium chloride as a preservative
• Dibasic anhydrous sodium phosphate
• Polysorbate 80 (Tween 80)
• Disodium edetate
• Sodium chloride
• Hypromellose
• Citric acid monohydrate and/or sodium hydroxide use to adjust pH
• Purified water.

Allergen:
May contain sulfites.

Supplier

Maxidex is supplied in Australia by:

Novartis Pharmaceuticals Australia Pty Limited
ABN 18 004 244 160
54 Waterloo Road
Macquarie Park NSW 2113
Telephone: 1-800-671-203.
Web site: www.novartis.com.au

Australian registration number

AUST R: 25354

Date of preparation

This leaflet was prepared in November 2022.

© Novartis Pharmaceuticals Australia Pty Limited 2022

® Registered trademark.

Internal document code:

(max181122c) based on PI (max181122i)

Published by MIMS January 2023

1 Name of Medicine

Dexamethasone.

2 Qualitative and Quantitative Composition

Maxidex eye drops contain 1 mg/mL dexamethasone and is preserved with benzalkonium chloride (0.1 mg/mL).
May contain potential allergen sulfites from the manufacturing process.
For a full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

The eye drops are a white to pale yellow, opaque suspension with no agglomerates.

4 Clinical Particulars

4.1 Therapeutic Indications

Steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe, such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitis when the inherent hazard of steroid use is accepted to obtain an advisable diminution in oedema and inflammation; corneal injury from chemical radiation or thermal burns or penetration of foreign bodies.

4.2 Dose and Method of Administration

One or two drops topically in the conjunctival sac(s). In severe disease, drops may be used hourly, being tapered to discontinuation as the inflammation subsides. In mild disease, drops may be used up to four to six times daily.
Nasolacrimal occlusion or gently closing the eyelid after administration is recommended. This may reduce the systemic absorption of medicinal products administered via the ocular route and result in a decrease in systemic adverse reactions.

Instructions to patients.

4.3 Contraindications

Maxidex eye drops are contraindicated in epithelial herpes simplex (dendritic keratitis), vaccinia, varicella and most other viral diseases of the cornea and conjunctiva, tuberculosis of the eye, fungal disease of ocular structures or untreated parasitic eye infections, mycobacterial ocular infections or untreated bacterial eye infections.
Those persons who have shown hypersensitivity to any component of this preparation.

4.4 Special Warnings and Precautions for Use

Not for injection or oral ingestion.
This drug is not effective in the treatment of Sjogren's keratoconjunctivitis. The extensive and/or prolonged use of ophthalmic steroids increases the risk of ocular complications and could cause systemic side effects. If the inflammatory condition does not respond within a reasonable period during the course of the therapy, other forms of therapy should be instituted to reduce these risks.
Prolonged use of ophthalmic steroids may result in ocular hypertension and/or glaucoma, with damage to the optic nerve, defect in visual acuity and fields of vision and posterior subcapsular cataract formation. The risk of corticosteroid-induced raised intraocular pressure is increased for a patient with a family or personal history of glaucoma or high myopia. If these products are used for 10 days or longer, intraocular pressure should be routinely and frequently monitored even though it may be difficult in children and uncooperative patients. The risk of corticosteroid-induced ocular hypertension may be greater in children and may occur earlier than in adults. Maxidex eye drops is not approved for use in paediatric patients. The risk of corticosteroid induced raised intraocular pressure and/or cataract formation is increased in predisposed patients (e.g. diabetes). Risk-benefit should be considered in a patient with diabetes mellitus as they may be predisposed to an increase in posterior subcapsular cataract formation.
Cushing's syndrome and/or adrenal suppression associated with systemic absorption of ophthalmic dexamethasone may occur after intensive or long-term continuous therapy in predisposed patients, including children and patients treated with CYP3A4 inhibitors (including ritonavir and cobicistat), see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions. In these cases, treatment should not be discontinued abruptly, but progressively tapered.
Corticosteroids may mask infection, reduce resistance to, enhance existing or established bacterial, viral, fungal or parasitic infection. Prolonged use may suppress the immune response and thus increase the hazard of secondary ocular infections. The possibility of persistent fungal infections of the cornea should be considered after prolonged corticosteroid dosing.
Fungal infection should be suspected in patients with persistent corneal ulceration who have been or are receiving these drugs, and corticosteroids therapy should be discontinued if fungal infection occurs.
Topical ophthalmic corticosteroids may slow corneal wound healing. Topical NSAIDs are also known to slow or delay healing. Concomitant use of topical NSAIDs and topical steroids may increase the potential for healing problems.
Ocular herpes simplex has occurred in patients under systemic or local corticosteroid therapy for other conditions. Employment of corticosteroid medication in the treatment of herpes simplex other than epithelial herpes simplex keratitis, in which it is contraindicated, requires great caution and only in conjunction with antiviral therapy; periodic slit-lamp microscopy is essential.
In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical corticosteroids.
Maxidex eye drops contains benzalkonium chloride which may cause eye irritation and is known to discolour soft contact lenses. Avoid contact with soft contact lenses. In case patients are allowed to wear contact lenses, they must be instructed to remove contact lenses prior to application of Maxidex eye drops and wait at least 15 minutes before reinsertion.

Visual disturbance.

Use in hepatic impairment.

Use in renal impairment.

Use in the elderly.

Paediatric use.

4.5 Interactions with Other Medicines and Other Forms of Interactions

An additional increase in intraocular pressure cannot be excluded if dexamethasone is used concomitantly with atropine or other anticholinergics which themselves may lead to IOP elevations in predisposed patients.
Concomitant use of topical steroids and topical NSAIDs may increase the potential for corneal healing problems.
CYP3A4 inhibitors including ritonavir and cobicistat may increase systemic exposure resulting in increased risk of adrenal suppression/Cushing's syndrome. (See Section 4.4 Special Warnings and Precautions for Use.) The combination should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side-effects, in which case patients should be monitored for systemic corticosteroid effects.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

Instillation of eye drops may cause transient blurring of vision or other visual disturbances may affect the ability to drive or use machines. If blurred vision occurs at instillation, the patient must wait until the vision clears before driving or using machinery.

4.8 Adverse Effects (Undesirable Effects)

Reporting suspected adverse effects.

Eye disorders.

Infections and infestations.

Injury, poisoning and procedural complications.

Investigations.

Skin and subcutaneous tissue disorders.

Post-marketing events.

Eye disorders.

Immune system disorders.

Nervous system disorders.

Endocrine disorders.

4.9 Overdose

For information on the management of overdose, contact the Poison Information Centre on 13 11 26 (Australia).
A topical overdose of Maxidex eye drops may be flushed from the eye(s) with tepid water. Accidental ingestion of Maxidex eye drops is not likely to be associated with toxicity. Treatment of any overdose is symptomatic and supportive.
lf acute overdose is suspected, Maxidex eye drops must be ceased immediately and appropriate assessment, monitoring and treatment commenced.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Topical ocular steroid administration has been demonstrated to be effective in the treatment of inflammatory non-infectious diseases of the anterior eye segment, the cornea, and conjunctiva.
Systemic administration is however required for the treatment of posterior eye segment disease.

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

The determination of the ocular availability of dexamethasone after topical ocular administration is based on patients undergoing cataract extraction. The maximum aqueous humor level was reached within 2 hours. The subsequent level decrease resulted in a half-life of 3 hours.

Placental transfer.

Excretion into human milk.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Maxidex eye drops contain 1 mg/mL dexamethasone, together with dibasic anhydrous sodium phosphate, polysorbate 80 (Tween 80), disodium edetate, sodium chloride, hypromellose and purified water. Citric acid monohydrate and/or sodium hydroxide are used to adjust the pH. The suspension is preserved with benzalkonium chloride (0.1 mg/mL).

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

Discard container 4 weeks after opening.
In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 25°C. Do not freeze.

6.5 Nature and Contents of Container

The eye drops are supplied in a 5 mL LDPE bottle with a LDPE plug and PP closure.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Chemical name: pregna-1,4-diene-3,20-dione,9-fluoro-11,17,21-trihydroxy-16-methyl-,(11β,16α).

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

Prescription Only Medicine (S4).

Summary Table of Changes